FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IISYS PACS SYSTEM
K Number: K980220
·
Decision Feb 13, 1998
Classifications
1
FEI Numbers
148
Registration Numbers
148
Same Product Code
141
Applicant Total
7
Review Days
22
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Basic Information
- Device Name
- IISYS PACS SYSTEM
- K Number
- K980220
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.2020
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Sterling Diagnostic Imaging, Inc.
- Date Received
- January 22, 1998
- Decision Date
- February 13, 1998
- Product Code
- LMD
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LMD | System, Digital Image Communications, Radiological | FDA class 1 | Radiology |
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Other Clearances by Sterling Diagnostic Imaging, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K980970 | IIRAD DIRECTRAY OPERATOR CONSOLE | Jun 8, 1998 | Substantially Equivalent |
| K974423 | ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAIL | Dec 22, 1997 | Substantially Equivalent |
| K973206 | STERLING DIAGNOSTIC IMAGING DIRECT RADIOGRAPHY | Dec 4, 1997 | Substantially Equivalent |
| K972660 | RAVEN DRY PRINTER | Nov 10, 1997 | Substantially Equivalent |
| K973028 | HELIOS LASER IMAGER 1417 | Oct 28, 1997 | Substantially Equivalent |
| K964250 | LINX NETWORKING SYSTEM | Dec 18, 1996 | Substantially Equivalent |